HealthyPhase 1NCT05005065
Evaluation of the Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of IN-C005 and IN-A001 in Healthy Caucasians
A Phase 1 study testing IN-C005 X mg, IN-A001 Y mg and IN-C005 Y mg in people with Healthy, run by HK inno.N Corporation at 2 sites in South Korea.
Trial summary
The purpose of this study is to evaluate pharmacokinetics/pharmacodynamics and safety/tolerability of IN-C005 and IN-A001 after oral administration in healthy Caucasian subjects. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- IN-C005 X mg, IN-A001 Y mg and IN-C005 Y mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 6 Sep 2021to 30 Nov 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is healthy Caucasian adult aged 19 to 50 years (inclusive) at the time of signing the informed consent form (ICF) (A Caucasian is defined as a European who was born in Europe, has the duration of residence outside of Europe less than 10 years, and both of whose parents and grandparents are European-born).
- Has ≥ 18.0 and ≤ 30.0 kg/m2 of body mass index (BMI) with a body weight (BW) ≥ 55.0 kg at screening.
- Has a negative result in serum Helicobacter pylori IgG antibody test.
- Decides to participate voluntarily in the study after being fully informed of and understanding the study completely, and provides his/her written informed consent prior to screening procedure.
- Is eligible for this study in the opinion of the investigator based on the results of physical examination, clinical laboratory tests, interview, etc.
Who cannot join
- Has a history or current evidence of clinically significant disorder of hepatic, renal, nervous, respiratory, endocrine, hemato-oncologic, cardiovascular, urinary, and/or psychiatric system.
- Has a history or current evidence of gastrointestinal disease that may affect the safety and PD assessments for study treatment (e.g., gastrointestinal ulcer, gastritis, gastric cramp, gastroesophageal reflux disease, and Crohn's disease) or a history of gastrointestinal surgery (except for simple appendectomy or herniotomy).
- Has a history or current evidence of clinically significant hypersensitivity to study drugs or any ingredient of proton pump inhibitors and other drugs (such as aspirin and antibiotics).
- Has a positive result on serology tests (for hepatitis B, human immunodeficiency virus [HIV], and hepatitis C).
- Has a blood level of total bilirubin, AST (GOT), or ALT (GPT) > 1.5 X upper limit of normal (ULN) based on screening procedures including repeated ones.
- Has a calculated eGFR per MDRD equation < 60 mL/min/1.73 m2 based on screening procedures including repeated ones.
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- Has systolic blood pressure (SBP) of < 90 mmHg or > 140 mmHg, diastolic blood pressure (DBP) of < 50 mmHg or > 95 mmHg, or pulse rate (PR) of < 45 beats/min or > 100 beats/min on vital signs as measured in sitting position after taking a rest for at least 5 minutes at screening.
- Has an anatomical disorder that precludes insertion and maintenance of intragastric pH meter catheter or is expected to be intolerable to insertion of intragastric pH meter catheter.
- Has a history of drug abuse or has a positive response to drug abuse on urine drug screening test.
- Has received any prescription drug or herbal medication within 2 weeks of or any over-the-counter (OTC) drug, dietary supplements, or vitamins within 1 week of scheduled first dose or is expected to receive such medication during the study (Note: a subject may participate in the study at the discretion of the investigator provided the subject meets all the other criteria).
- Has participated and received an investigational agent in another clinical trial or bioequivalence study within 6 months prior to the first dose of study treatment (Note: This is not applied to participation in another part of this study).
- Has donated whole blood within 2 months prior to the scheduled first dose, or has donated blood components or received transfusion within a month prior to the scheduled first dose.
- Has excessive caffeine intake (> 5 units/day), continues the use of alcohol (> 21 units/week, 1 unit = 10 g of pure alcohol), or is unable to stop drinking during hospitalization period.
- Has a positive result for cotinine on urine drug screening test or is unable to stop smoking throughout the study.
- Is unable to avoid grapefruit-containing foods during the time from 24 hours (hrs) before hospitalization to discharge in Period 1 and Period 2, respectively.
- Is unable to avoid caffeine-containing foods (e.g., coffee, tea [red tea, green tee, etc.], soda, coffee milk, and nutritive tonic drink) during the time from 24 hrs before hospitalization to discharge Period 1 and Period 2, respectively.
- For all women of childbearing potential (WOCBP) excluding those on amenorrhea for at least 12 months and those who underwent surgical sterilization (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), has a positive result for pregnancy test (urine hCG) performed prior to the first dose of study treatment or is pregnant or breastfeeding.
- Is unable to use a medically acceptable contraceptive method throughout the study. Medically acceptable contraceptive methods include:
- Use of an intrauterine device with a proven birth control failure rate by the subject or subject's spouse (or partner)
- Use of (male or female) barrier method with spermicide
- Surgical sterilization (vasectomy, salpingectomy, tubal ligation, hysterectomy) of the subject or subject's spouse (or partner)
- Is determined ineligible for study participation by the investigator for other reasons such as clinical laboratory abnormalities.
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul National University Hospital
Seoul, Jongro Gu, 03080
Seoul National University Hopsital
Seoul, 03080
About this study
Official title: A Randomized, Open-label, Multiple Dosing, Cross-over Phase 1 Clinical Trial to Evaluate Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of IN-C005 and IN-A001 After Oral Administration in Healthy Caucasian Subjects
The purpose of this study is to evaluate pharmacokinetics/pharmacodynamics and safety/tolerability of IN-C005 and IN-A001 after oral administration in healthy Caucasian subjects.
Read the detailed description
[Part 1] To evaluate the pharmacokinetic (PK)/pharmacodynamic (PD) profiles and safety/tolerability of 100 mg IN-C005 versus 100 mg IN-A001 after multiple oral dosing in healthy Caucasian subjects
[Part 2] To evaluate the PK/PD profiles and safety/tolerability of 50 mg IN-C005 versus 75 mg IN-C005 after multiple oral dosing in healthy Caucasian subjects
- Conditions
- Healthy
- Being tested
- IN-C005 X mg, IN-A001 Y mg, IN-C005 Y mg, IN-C005 Z mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IN-C005 X mgDrug
Oral capsule
IN-A001 Y mgDrug
Oral tablet
IN-C005 Y mgDrug
Oral capsule
IN-C005 Z mgDrug
Oral capsule
| Study group | Role | What they receive |
|---|---|---|
| Treatment AB | Experimental | Participants will be randomized to receive IN-C005 Y mg (Treatment A) and IN-A001 Y mg (Treatment B) sequentially in a two-period sequence. There will be a washout period of at least 14 days between Period 1 and Period 2. Receives: Drug: IN-A001 Y mg; Drug: IN-C005 Y mg |
| Treatment BA | Experimental | Participants will be randomized to receive IN-A001 Y mg and IN-C005 Y mg sequentially in a two-period sequence. There will be a washout period of at least 14 days between Period 1 and Period 2. Receives: Drug: IN-A001 Y mg; Drug: IN-C005 Y mg |
| Treatment CD | Experimental | Participants will be randomized to receive IN-C005 Z mg (Treatment C) and IN-C005 X mg (Treatment D) sequentially in a two-period sequence. There will be a washout period of at least 14 days between Period 1 and Period 2. Receives: Drug: IN-C005 X mg; Drug: IN-C005 Z mg |
| Treatment DC | Experimental | Participants will be randomized to receive IN-C005 X mg and IN-C005 Z mg sequentially in a two-period sequence. There will be a washout period of at least 14 days between Period 1 and Period 2. Receives: Drug: IN-C005 X mg; Drug: IN-C005 Z mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
PK: Maximum concentration of drug in plasma
Measured: Day 1, Day 22
AUClast
PK: Area under the plasma drug concentration-time curve from 0 to last point of measurable concentration
Measured: Day 1, Day 22
Cmax,ss
PK: Maximum (peak) steady-state plasma drug concentration during a dosage interval
Measured: Day 7 and Day 28
AUCtau,ss
PK: Area under the plasma drug concentration-time curve for a dosing interval at steady state
Measured: Day 7 and Day 28
Percent duration of pH ≥4 in 24 hrs (duration %)
PD: pH parameter
Measured: Day 1, Day 22
Percent duration of pH ≥4 in 24 hrs (duration %)
PD: pH parameter
Measured: Day 7, Day 28
Change from baseline in percent duration of pH ≥4 in 24 hrs
PD: pH parameter
Measured: Day 1, Day 7, Day 22, Day 28
Secondary outcomes (24)
AUCinf
PK: Area under the plasma drug concentration-time curve from time 0 to infinity
Measured: Day 1, Day 22
Tmax
PK: The time of peak concentration
Measured: Day 1, Day 22
t1/2
PK: Terminal half-life
Measured: Day 1, Day 22
CL/F
PK: Apparent Clearance
Measured: Day 1, Day 22
Vd/F
PK: Apparent volume of distribution after extravascular administration
Measured: Day 1, Day 22
Tmax,ss
PK: Time to reach Cmax
Measured: Day 7, Day 28
t1/2,ss
PK: Apparent first order terminal elimination half-life
Measured: Day 7, Day 28
Cmin,ss
PK: Minimum observed non zero concentration between dose time and dose time + dosing interval, tau
Measured: Day 7, Day 28
Cavg,ss
PK: The average concentration at steady state, calculated as the ratio of AUCtau to the dosing interval, tau
Measured: Day 7, Day 28
CLss/F
PK: The total body clearance at steady state after oral administration
Measured: Day 7, Day 28
Vd,ss/F
PK: Apparent volume of distribution after extravascular administration in steady state
Measured: Day 7, Day 28
PTF
PK: Peak to trough fluctuation
Measured: Day 7, Day 28
R
PK: Accumulation ratio
Measured: Day 7, Day 28
Percent duration of pH ≥3 in 24 hrs
PD: pH parameter
Measured: Day 1, Day 7, Day 22, Day 28
Change from baseline in percent duration of pH ≥3 in 24 hrs
PD: pH parameter
Measured: Day 1, Day 7, Day 22, Day 28
Percent duration of pH ≥6 in 24 hrs
PD: pH parameter
Measured: Day 1, Day 7, Day 22, Day 28
Change from baseline in percent duration of pH ≥6 in 24 hrs
PD: pH parameter
Measured: Day 1, Day 7, Day 22, Day 28
Mean and median pH in 24 hrs
PD: pH parameter
Measured: Day 1, Day 7, Day 22, Day 28
Change from baseline in mean pH in 24 hrs
PD: pH parameter
Measured: Day 1, Day 7, Day 22, Day 28
Change from baseline in median pH in 24 hrs
PD: pH parameter
Measured: Day 1, Day 7, Day 22, Day 28
AUEGlast
PD(Gastrin): Area under the concentration-time curve of Serum Gastrin from 0 to last point of quantifiable concentration
Measured: Day 1, Day 7, Day 22, Day 28
Gmax
Gastrin: Maximum gastrin level
Measured: Day 1, Day 7, Day 22, Day 28
ΔAUEGlast
PD(Gastrin): Change from baseline in AUEGlast
Measured: Day 1, Day 7, Day 22, Day 28
ΔGmax
PD(Gastrin): Change from baseline in Gmax
Measured: Day 1, Day 7, Day 22, Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start6 Sep 2021
- Primary completion18 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by HK inno.N CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, open-label, multiple dosing, crossover study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- In-Jin Jang, MD, Ph.D, Principal investigator, Clinical Pharmacology and Therapeutics, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005065
- Sponsor's protocol ID
- IN_BTK_102
- Status last verified
- Aug 2021
- First submitted
- 5 Jul 2021
- Last updated
- 16 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multiple Dosing, Cross-over Phase 1 Clinical Trial to Evaluate Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of IN-C005 and IN-A001 After Oral Administration in Healthy Caucasian Subjects
- ClinicalTrials.gov ID
- NCT05005065
- Acronym / sponsor ID
- IN_BTK_102
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 18 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 13 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate pharmacokinetics/pharmacodynamics and safety/tolerability of IN-C005 and IN-A001 after oral administration in healthy Caucasian subjects.
Detailed description
[Part 1] To evaluate the pharmacokinetic (PK)/pharmacodynamic (PD) profiles and safety/tolerability of 100 mg IN-C005 versus 100 mg IN-A001 after multiple oral dosing in healthy Caucasian subjects
[Part 2] To evaluate the PK/PD profiles and safety/tolerability of 50 mg IN-C005 versus 75 mg IN-C005 after multiple oral dosing in healthy Caucasian subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Randomized, open-label, multiple dosing, crossover study
| Arm | Type | Receives |
|---|---|---|
| Treatment AB | Experimental | Drug: IN-A001 Y mg, Drug: IN-C005 Y mgParticipants will be randomized to receive IN-C005 Y mg (Treatment A) and IN-A001 Y mg (Treatment B) sequentially in a two-period sequence. There will be a washout period of at least 14 days between Period 1 and Period 2. |
| Treatment BA | Experimental | Drug: IN-A001 Y mg, Drug: IN-C005 Y mgParticipants will be randomized to receive IN-A001 Y mg and IN-C005 Y mg sequentially in a two-period sequence. There will be a washout period of at least 14 days between Period 1 and Period 2. |
| Treatment CD | Experimental | Drug: IN-C005 X mg, Drug: IN-C005 Z mgParticipants will be randomized to receive IN-C005 Z mg (Treatment C) and IN-C005 X mg (Treatment D) sequentially in a two-period sequence. There will be a washout period of at least 14 days between Period 1 and Period 2. |
| Treatment DC | Experimental | Drug: IN-C005 X mg, Drug: IN-C005 Z mgParticipants will be randomized to receive IN-C005 X mg and IN-C005 Z mg sequentially in a two-period sequence. There will be a washout period of at least 14 days between Period 1 and Period 2. |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Is healthy Caucasian adult aged 19 to 50 years (inclusive) at the time of signing the informed consent form (ICF) (A Caucasian is defined as a European who was born in Europe, has the duration of residence outside of Europe less than 10 years, and both of whose parents and grandparents are European-born).
- Has ≥ 18.0 and ≤ 30.0 kg/m2 of body mass index (BMI) with a body weight (BW) ≥ 55.0 kg at screening.
- Has a negative result in serum Helicobacter pylori IgG antibody test.
- Decides to participate voluntarily in the study after being fully informed of and understanding the study completely, and provides his/her written informed consent prior to screening procedure.
- Is eligible for this study in the opinion of the investigator based on the results of physical examination, clinical laboratory tests, interview, etc.
Key exclusion criteria (22 listed)
- Has a history or current evidence of clinically significant disorder of hepatic, renal, nervous, respiratory, endocrine, hemato-oncologic, cardiovascular, urinary, and/or psychiatric system.
- Has a history or current evidence of gastrointestinal disease that may affect the safety and PD assessments for study treatment (e.g., gastrointestinal ulcer, gastritis, gastric cramp, gastroesophageal reflux disease, and Crohn's disease) or a history of gastrointestinal surgery (except for simple appendectomy or herniotomy).
- Has a history or current evidence of clinically significant hypersensitivity to study drugs or any ingredient of proton pump inhibitors and other drugs (such as aspirin and antibiotics).
- Has a positive result on serology tests (for hepatitis B, human immunodeficiency virus [HIV], and hepatitis C).
- Has a blood level of total bilirubin, AST (GOT), or ALT (GPT) > 1.5 X upper limit of normal (ULN) based on screening procedures including repeated ones.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IN-C005 X mgOral capsule | Drug | Treatment CD, Treatment DC |
| IN-A001 Y mgOral tablet | Drug | Treatment AB, Treatment BA |
| IN-C005 Y mgOral capsule | Drug | Treatment AB, Treatment BA |
| IN-C005 Z mgOral capsule | Drug | Treatment CD, Treatment DC |
Primary outcome
Cmax
Time frame: Day 1, Day 22
PK: Maximum concentration of drug in plasma
AUClast
Time frame: Day 1, Day 22
PK: Area under the plasma drug concentration-time curve from 0 to last point of measurable concentration
Cmax,ss
Time frame: Day 7 and Day 28
PK: Maximum (peak) steady-state plasma drug concentration during a dosage interval
AUCtau,ss
Time frame: Day 7 and Day 28
PK: Area under the plasma drug concentration-time curve for a dosing interval at steady state
Percent duration of pH ≥4 in 24 hrs (duration %)
Time frame: Day 1, Day 22
PD: pH parameter
Percent duration of pH ≥4 in 24 hrs (duration %)
Time frame: Day 7, Day 28
PD: pH parameter
Change from baseline in percent duration of pH ≥4 in 24 hrs
Time frame: Day 1, Day 7, Day 22, Day 28
PD: pH parameter
24 secondary outcomes
AUCinf
Time frame: Day 1, Day 22
Tmax
Time frame: Day 1, Day 22
t1/2
Time frame: Day 1, Day 22
CL/F
Time frame: Day 1, Day 22
Vd/F
Time frame: Day 1, Day 22
Tmax,ss
Time frame: Day 7, Day 28
t1/2,ss
Time frame: Day 7, Day 28
Cmin,ss
Time frame: Day 7, Day 28
Cavg,ss
Time frame: Day 7, Day 28
CLss/F
Time frame: Day 7, Day 28
Vd,ss/F
Time frame: Day 7, Day 28
PTF
Time frame: Day 7, Day 28
R
Time frame: Day 7, Day 28
Percent duration of pH ≥3 in 24 hrs
Time frame: Day 1, Day 7, Day 22, Day 28
Change from baseline in percent duration of pH ≥3 in 24 hrs
Time frame: Day 1, Day 7, Day 22, Day 28
Percent duration of pH ≥6 in 24 hrs
Time frame: Day 1, Day 7, Day 22, Day 28
Change from baseline in percent duration of pH ≥6 in 24 hrs
Time frame: Day 1, Day 7, Day 22, Day 28
Mean and median pH in 24 hrs
Time frame: Day 1, Day 7, Day 22, Day 28
Change from baseline in mean pH in 24 hrs
Time frame: Day 1, Day 7, Day 22, Day 28
Change from baseline in median pH in 24 hrs
Time frame: Day 1, Day 7, Day 22, Day 28
AUEGlast
Time frame: Day 1, Day 7, Day 22, Day 28
Gmax
Time frame: Day 1, Day 7, Day 22, Day 28
ΔAUEGlast
Time frame: Day 1, Day 7, Day 22, Day 28
ΔGmax
Time frame: Day 1, Day 7, Day 22, Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
In-Jin Jang, MD, Ph.D principal investigator
Clinical Pharmacology and Therapeutics, Seoul National University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IN-C005 X mg, IN-A001 Y mg and IN-C005 Y mg in people with Healthy, run by HK inno.N Corporation at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: Day 1, Day 22). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2022.